Atopic Dermatitis
Conditions
Brief summary
To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.
Interventions
DRUGExtended release tacrolimus (Advagraf®)
Sponsors
UMC Utrecht
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects.
Exclusion criteria
* Concomitant use of other oral immunosuppressive drugs and/or UV light therapy * Preexisting abnormalities in liver function, kidney function or haematological abnormalities * History of malignancy within the last 5 years * Uncontrolled hypertension * Pregnancy or lactation; wish for pregnancy during the treatment period * Infections requiring continued therapy * Known positivity for HIV * Evidence of drug and/or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scoring Atopic Dermatitis (SCORAD) | Every 4 weeks up to one year | Clinical eczema scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Oriented Eczema Measure (POEM) | Every 4 weeks up to one year | Self administered eczema score |
| Change in Thymus and Activation-Regulated Chemokine in serum (TARC) | Every 4 weeks up to one year | Biomarker atopic dermatitis |
Countries
Netherlands
Outcome results
None listed